Early CPAP in Respiratory Distress Syndrome

December 23, 2010 updated by: Pontificia Universidad Catolica de Chile

Early Bubble CPAP (EBCPAP) in Very Low Birth Weight Infants (VLBWI)

The purpose of this study is to establish if a strategy of EBCPAP application in a subgroup of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The application of CPAP has been described as an alternative respiratory support for premature newborns with respiratory distress.Many studies support that the early use of CPAP results in a better respiratory evolution and less need for mechanical ventilation.

Hypothesis:

- The hypothesis is that EBCPAP will decrease the need for this more invasive therapy.

The primary endpoint in this multicenter controlled study is to establish if an strategy of EBCPAP application in a subgroup of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality. .

As secondary outcome, the investigators will analyse: days of oxygen therapy, days of mechanical ventilation, need for surfactant , pulmonary airleak, intraventricular hemorrhage, persistent ductus arteriosus, retinopathy of prematurity and bronchopulmonary dysplasia (BPD) at 28 days and 36 weeks corrected gestational age.

Comparison(s):

Early Bubble CPAP (EBCPAP)with Standard Therapy which is oxygen.

Study Type

Interventional

Enrollment (Anticipated)

256

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Recruiting
        • Servicio de Neonatología, Hospital de Clínicas José de San Martín
        • Contact:
        • Sub-Investigator:
          • Isabel Kurlat, MD
      • Buenos Aires, Argentina
        • Recruiting
        • Servicio de Neonatología, Hospital Fernández
        • Contact:
        • Sub-Investigator:
          • Liliana Roldan, MD
      • Buenos Aires, Argentina
      • Buenos Aires, Argentina
        • Recruiting
        • Servicio de Neonatología, Maternidad Sardá
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Carlos Grandi, MD
      • Mendoza, Argentina
        • Recruiting
        • Servicio de Neonatología, Hospital Lagomaggiore
        • Contact:
        • Sub-Investigator:
          • Augusto Fischetti, MD
  • Chile
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile
        • Recruiting
        • Servicio de Neonatología, Hospital Clínico Universidad de Chile
        • Contact:
        • Sub-Investigator:
          • Jaime Burgos, MD
      • Santiago, Región Metropolitana, Chile
        • Not yet recruiting
        • Servicio de Neonatología, Hospital San José
        • Contact:
        • Sub-Investigator:
          • Agustina Gonzalez, MD
      • Santiago, Región Metropolitana, Chile
        • Not yet recruiting
        • Servicio de Neonatología, Hospital Sótero del Rio
        • Contact:
        • Sub-Investigator:
          • Patricia Mena, MD
      • Santiago, Región Metropolitana, Chile
        • Recruiting
        • Unidad de Neonatología, Hospital Clínico Pontificia Universidad Católica
        • Contact:
        • Contact:
        • Principal Investigator:
          • Soledad Urzúa, MD
    • V Región
      • Viña del Mar, V Región, Chile
        • Suspended
        • Servicio de Neonatología, Hospital Gustavo Fricke
    • VIII Región
      • Concepción, VIII Región, Chile
        • Recruiting
        • Servicio de Neonatología, Hospital Guillermo Grant
        • Contact:
        • Principal Investigator:
          • Aldo Bancalari, MD
  • Paraguay
      • Asuncion, Paraguay
        • Not yet recruiting
        • Servicio de Neonatología, Hospital de Clinicas Universidad Nacional Asunción
        • Contact:
        • Contact:
        • Sub-Investigator:
          • José Lacarruba, MD
  • Peru
      • Lima, Peru
  • Uruguay
      • Montevideo, Uruguay
        • Not yet recruiting
        • Servicio de neonatología, Centro Hospitalario Pereira Rosseli
        • Contact:
        • Sub-Investigator:
          • Ruben Panizza, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 minutes to 30 minutes (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All infants born at the units belonging to the South American Neocosur Network with a birthweight between 800 to 1500g and breathing spontaneously at birth or after hand bagging with Neopuff or transient intubation are eligible.
  • An informed consent form should be obtained preferable prenatal.

Exclusion Criteria:

  • Acute life threatening congenital malformations or genetics diseases.
  • Apgar score equal or less than 3 at 5 minutes
  • Disapproval of informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Need for mechanical ventilation

Secondary Outcome Measures

Outcome Measure
Intraventricular hemorrhage
retinopathy of prematurity
Days of oxygen therapy
Days of mechanical ventilation
Need for surfactant
Pulmonary airleak
Persistent ductus arteriosus
Bronchopulmonary dysplasia (BPD) at 28 days and 36 weeks corrected gestational age.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Investigators

  • Principal Investigator: José Luis Tapia, MD, Pontificia Universidad Católica
  • Principal Investigator: Aldo Bancalari, MD, Hospital Guillermo Grant
  • Principal Investigator: Soledad Urzua, MD, Pontificia Universidad Católica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion

April 1, 2008

Study Completion

September 1, 2009

Study Registration Dates

First Submitted

August 24, 2006

First Submitted That Met QC Criteria

August 24, 2006

First Posted (Estimate)

August 25, 2006

Study Record Updates

Last Update Posted (Estimate)

December 24, 2010

Last Update Submitted That Met QC Criteria

December 23, 2010

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEO032006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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